Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55737 

gynecological biopsy forceps that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, the 

exemption from premarket notification 

does not apply and the manufacturer 

must submit a premarket notification 

that includes validation data as 

described in § 807.3(v). 

■ 60. Section 884.6100 is amended by 

revising paragraph (b) to read as follows: 

§ 884.6100 Assisted reproduction needles. 

* * * * * 

(b) Classification. Class II (special 

controls) (mouse embryo assay 

information, endotoxin testing, 

sterilization validation, design 

specifications, labeling requirements, 

biocompatibility testing, and clinical 

testing). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

PART 886—OPTHALMIC DEVICES 

■ 61. The authority citation for 21 CFR 

part 886 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 62. Section 886.4350 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4350 Manual ophthalmic surgical 

instrument . 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter, 

subject to the limitations in § 886.9. If 

the device is an ophthalmic knife that 

is a reprocessed single use device (SUD) 

as defined in § 807.3(u) of this chapter, 

the exemption from premarket 

notification does not apply and the 

manufacturer must submit a premarket 

notification that includes validation 

data as described in § 807.3(v). 

■ 63. Section 886.4370 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4370 Keratome. 

* * * * * 

(b) Classification. Class I (general 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 64. Section 886.4670 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4670 Phacofragmentation system. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a 

phacoemulsification needle that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

PART 892—RADIOLOGY DEVICES 

■ 65. The authority citation for 21 CFR 

part 892 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 66. Section 892.5730 is amended by 

revising paragraph (b) to read as follows: 

§ 892.5730 Radionuclide brachytherapy 

source. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an isotope 

needle that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

Dated: September 6, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8166 Filed 9–22–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP San Francisco Bay 06–022] 

RIN 1625–AA00 

Safety Zone; BART Transbay Tube 

Seismic Upgrade, San Francisco, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a moving temporary safety 

zone in the navigable waters of San 

Francisco Bay, California during vibro 

penetration testing for a seismic upgrade 

of the Bay Area Rapid Transit (BART) 

Transbay tube. The testing will require 

placement of a barge at test sites along 

the BART Transbay tube. The safety 

zone will surround the barge and move 

with the barge as it conducts the tests 

at seven sites along the BART Transbay 

tube. This safety zone is necessary to 

protect persons and vessels from 

hazards, injury, and damage associated 

with the vibro penetration testing. 

Unauthorized persons or vessels are 

prohibited from entering into, transiting 

through, or remaining in the safety zone 

without permission of the Captain of the 

Port or his designated representative. 

DATES: This rule is effective from 

September 25, 2006 through December 

31, 2006. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket COTP San 

Francisco Bay 06–022 and are available 

for inspection or copying at the 

Waterways Safety Branch of Sector San 

Francisco, Yerba Buena Island, Bldg. 

278, San Francisco, California, 94130, 

between 9 a.m. and 4 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Erin Bastick, U.S. Coast Guard 

Sector San Francisco, at (415) 556–2950 

or Sector San Francisco 24 hour 

Command Center at (415) 399–3547. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing an NPRM. The dates 

for the vibro penetration testing along 

the Transbay tube were not finalized 

and presented to the Coast Guard in 

time to draft and publish an NPRM. As 

such, the testing would commence 

before the rulemaking process could be 

completed. Any delay in implementing 

this rule is contrary to the public 

interest since immediate action is 

necessary in order to protect the 

maritime public from the hazards 

associated with the vibro penetration 

testing. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. The dates for the vibro 

penetration testing along the Transbay 

tube were not finalized and presented to 

the Coast Guard in time to publish this 

rule 30 days prior to its effective date. 

As such, the testing would commence 

before the rulemaking process could be 

completed. Delay in the effective date of 

this rule would expose the mariners and 

waterways users to undue hazards 

associated with the vibro penetration 

testing. 

Background and Purpose 

Bay Area Rapid Transit has contracted 

Hayward Baker, Soletanche, Traylor, A 

Joint Venture, to conduct BART marine 

demonstration tests in support of their 

earthquake safety efforts. They will be 


cprice-sewell on PROD1PC66 with RULES
55738 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 

conducting vibro penetration tests for 

future seismic upgrade of the BART 

Transbay tube. The scope of work 

involves four primary activities carried 

out on the water. These activities 

include vibro penetration tests, vibro 

ground improvement, drilling, sampling 

and sonic borings. 

The Joint Venture’s work will involve 

outfitting the barge DOGBONE with a 

crane and vibratory densification 

equipment and locating it over the tube 

alignment to perform the ground 

improvement with in the test areas. At 

times there will be an additional barge 

lashed to the barge DOGBONE for 

material handling. Approximately ten 5- 

foot tall tripods with acoustic 

transponders will be deployed on the 

bay bottom to determine specific test 

locations along the BART Transbay. At 

each specified location the crane 

suspended vibrator will be lowered into 

the bay floor and then proceed to 

densify the granular backfill placed 

around the tubes shortly after they were 

originally placed into position. 

Discussion of Rule 

This safety zone will encompass the 

navigable waters from the surface to the 

sea floor, located in the San Francisco 

Bay, encompassing a circular safety 

zone with a 750-foot radius extending 

from the Crane Barge DOGBONE. The 

Barge DOGBONE will transit and 

conduct testing along the BART 

Transbay tube between two points: 

37°47′50.97′′ N Latitude by 

122°23′17.01′′ W Longitude at the 

western extreme and 37°48′25.65′′ N 

Latitude by 122°21′03.59′′ W Longitude 

on the eastern extreme. This area 

between the two points will be used to 

maneuver and anchor the Barge 

DOGBONE as it conducts the vibro 

penetration tests from September 25, 

2006 through December 31, 2006. The 

BART Project manager coordinated the 

test locations with the local Bar Pilots 

and the Vessel Traffic Service to ensure 

the testing would result in minimum 

impact to vessel traffic. This moving 

safety zone around the Barge DOGBONE 

is necessary to protect persons and 

vessels from hazards, injury, and 

damage associated with the vibro 

penetration testing. 

U.S. Coast Guard personnel will 

enforce this safety zone. Other Federal, 

State, or local agencies may assist the 

Coast Guard, including the Coast Guard 

Auxiliary. Section 165.53 of Title 33, 

Code of Federal Regulations, prohibits 

any unauthorized person or vessel from 

entering or remaining in a safety zone. 

Vessels or persons violating this section 

may be subject to both criminal and 

civil penalties. 

Regulatory Evaluation 

This rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. 

Although this rule restricts access to 

the waters encompassed by the safety 

zone, the effect of this rule will not be 

significant because the local waterway 

users have been contacted to ensure the 

closure will result in minimum impact. 

The entities most likely to be affected 

are pleasure craft engaged in 

recreational activities. Not only is the 

safety zone small in size, but there will 

be ample space to navigate around the 

safety zone as well. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b) that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

This rule will affect the following 

entities, some of which may be small 

entities: the owners or operators of 

vessels intending to transit or anchor in 

a portion of the San Francisco Bay from 

September 25, 2006 through December 

31, 2006. 

We expect this rule may affect owners 

and operators of vessels, some of which 

may be small entities, intending to fish, 

sightsee, transit, or anchor in the waters 

affected by this safety zone. This safety 

zone will not have a significant 

economic impact on a substantial 

number of small entities for several 

reasons: small vessel traffic will be able 

to pass safely around the area and 

vessels engaged in recreational 

activities, sightseeing and commercial 

fishing have ample space outside of the 

safety zone to engage in these activities. 

The entities most likely to be affected 

are pleasure craft engaged in 

recreational activities and sightseeing. 

Small entities and the maritime 

public will also be advised of this safety 

zone via public broadcast notice to 

mariners. In addition, vessels will be 

able to pass through the zone on a caseby-case basis. Therefore, the economic 

impact of this waterway closure is not 

expected to be significant. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we offered to assist small entities in 

understanding the rule so that they 

could better evaluate its effects on them 

and participate in the rulemaking 

process. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1–

888–REG–FAIR (1–888–734–3247). 

Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that Order and have 

determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this rule will not result in such 

expenditure, we do discuss the effects of 

this rule elsewhere in this preamble. 

Taking of Private Property 

This rule will not affect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 


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Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55739 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Commandant Instruction M16475.lD 

and Department of Homeland Security 

Management Directive 5100.1, which 

guide the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (NEPA) (42 U.S.C. 4321–

4370f), and have concluded that there 

are no factors in this case that would 

limit the use of a categorical exclusion 

under section 2.B.2 of the Instruction. 

Therefore, this rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction, from further 

environmental documentation. 

Paragraph (34)(g) is applicable because 

this rule establishes a safety zone. 

A final ‘‘Environmental Analysis 

Check List’’ and a final ‘‘Categorical 

Exclusion Determination’’ will be 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701; 50 U.S.C. 191; 33 CFR 1.05–1(g), 

6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 

116 Stat. 2064; Department of Homeland 

Security Delegation No. 0170.1. 

■ 2. Add § 165.T11–146, to read as 

follows: 

§ 165.T11–110 Safety Zone; San Francisco 

Bay, California. 

(a) Location. This safety zone will 

encompass the navigable waters from 

the surface to the sea floor, in the San 

Francisco Bay, and its limits will 

encompass a circular safety zone with a 

radius of 750-feet extending from and 

around the Crane Barge DOGBONE. 

This safety zone will move and continue 

to extend 750-feet from the Barge 

DOGBONE while it operates along the 

charted BART Transbay tube between 

the following two points: 37°47′50.97′′ N 

Latitude, by 122°23′17.01′′W Longitude 

at the western extreme, and 

37°48′25.65′′N Latitude by 

122°21′03.59′′W Longitude at the eastern 

extreme. 

(b) Effective Dates.This rule is 

effective from September 25, 2006 

through December 31, 2006. If the need 

for the safety zone ends prior to the 

scheduled termination time, the Captain 

of the Port (COTP) will cease 

enforcement of the safety zone. 

(c) Regulations. In accordance with 

the general regulations in § 165.23 of 

this part, entry into, transit through, or 

anchoring within this safety zone by all 

vessels and persons is prohibited, 

unless specifically authorized by the 

COTP San Francisco, or his designated 

representative. 

(d) Enforcement. All persons and 

vessels shall comply with the 

instructions of the Coast Guard COTP or 

his designated representative. The 

COTP’s designated representative can be 

comprised of commissioned, warrant, 

and petty officers of the Coast Guard 

onboard Coast Guard, Coast Guard 

Auxiliary, local, State, and Federal law 

enforcement vessels. Upon being hailed 

by U.S. Coast Guard patrol personnel by 

siren, radio, flashing light, or other 

means, the operator of a vessel shall 

proceed as directed. 

The U.S. Coast Guard may be assisted 

in the patrol and enforcement of these 

two safety zones by local law 

enforcement as necessary. 

Dated: September 8, 2006. 

W.J. Uberti, 

Captain, U.S. Coast Guard, Captain of the 

Port, San Francisco, California. 

[FR Doc. 06–8132 Filed 9–22–06; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP Western Alaska 06–003] 

RIN 1625–AA00 

Safety Zone; Gulf of Alaska, Narrow 

Cape, Kodiak Island, AK 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone in 

the Gulf of Alaska, encompassing the 

navigable waters in the vicinity of 

Narrow Cape and Ugak Island. The zone 

is needed to protect persons and vessels 

operating in the vicinity of the safety 

zone during a rocket launch from the 

Alaska Aerospace Development 

Corporation, Narrow Cape, Kodiak 


cprice-sewell on PROD1PC66 with RULES